NCT07054437

Brief Summary

Artificial intelligence (AI) is currently one of the global focal points for industrial development, with its applications in healthcare steadily increasing, such as in disease prediction, image diagnosis, and drug development. AI assists healthcare professionals in clinical decision-making by training relevant models through algorithms, thereby enhancing medical efficiency and quality. Currently, standardized tools are used in clinical settings to screen and assess various aspects of child development. Children's motor development levels are determined by comparing their performance against established norms. However, the current assessment methods primarily rely on on-site visual observation and recording by evaluators, which demands significant time and human resources. This research aims to establish an automated screening tool for gross motor development in early intervention, suitable for independently walking children aged one to six years old in Taiwan. The goal is to reduce the time cost of manual assessment and enable remote healthcare applications.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

June 10, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 10, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

artificial intelligencemachine learningneural networks

Outcome Measures

Primary Outcomes (1)

  • Accuracy of AI-based gross motor development screening model compared to pediatric therapist's CDIIT gross motor subscale assessment

    Accuracy will be calculated by comparing the AI model's classification results to pediatric therapists' assessments based on the CDIIT gross motor subscale. The accuracy formula is: (True Positive + True Negative) / Total number of cases.

    Day 1 (single assessment at enrollment).

Interventions

This intervention is an automated gross motor development screening tool specifically designed for independently walking children aged one to six years old in Taiwan. What sets it apart is its use of artificial intelligence (AI) algorithms to analyze motion data, enabling early identification of potential gross motor developmental delays. Unlike traditional methods that rely on manual, visual observation and subjective recording by healthcare professionals, this tool aims to significantly reduce assessment time and human resource costs. Furthermore, its automated nature makes it uniquely suited for telemedicine applications, allowing for remote screenings and overcoming geographical barriers to access early intervention services. The tool will be developed and validated against established developmental norms relevant to the Taiwanese population.

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from individuals referred for early intervention assessments at hospitals.

You may qualify if:

  • Legal guardian willing to provide written informed consent.
  • Males and females aged 1 to 6 years old.
  • Capable of independent walking.

You may not qualify if:

  • \- Non-native Chinese speakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 8, 2025

Study Start

June 11, 2025

Primary Completion (Estimated)

June 11, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations